Model Number URF-V2 |
Device Problem
Physical Resistance/Sticking (4012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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The subject device was not returned to omsc for evaluation but was returned to sorc.Sorc checked the subject device and found the reported phenomenon which was caused by the corrosion of the angulation mechanism due to the water leakage of the control section.The exact cause of the reported event could not be conclusively determined at this time.If additional information is received, this report will be supplemented.
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Event Description
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Olympus medical systems corp.(omsc) was informed that during the incoming inspection for repair at olympus service operation repair center (sorc), it was found that the angulation lock occurred.The occurrence date of the event is unknown.There was no report of patient injury associated with the event.
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Manufacturer Narrative
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This supplemental report is being submitted to provide additional information.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.The exact cause of the reported event could not be conclusively determined.However, based on the reported information, omsc presumed that the angulation lock was caused by the corrosion of the angulation mechanism due to the water leakage.If additional information becomes available, this report will be supplemented.
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Search Alerts/Recalls
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